Methods for surgical navigation

ABSTRACT

Methods for surgical navigation use a trajectory frame/guide assembly for use with surgical navigation systems that includes a base having a patient access aperture formed therein. A yoke is mounted to the base and is rotatable about a roll axis. A platform is mounted to the yoke and is rotatable about a pitch axis and interchangeably holds a single lumen or multi-lumen guide array and a device guide. A device guide can be rotated to align an access channel with a desired lumen path. No x-y actuators are required and a virtual guide array may also or alternatively be used to identify a desired open channel in the device guide for the preferred trajectory path.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/934,165, filed Mar. 23, 2018, which claims the benefit of andpriority to U.S. Provisional Application Ser. No. 62/488,192, filed Apr.21, 2017, the contents of which are hereby incorporated by reference asif recited in full herein.

FIELD OF THE INVENTION

The present invention relates generally to medical systems and methodsand, more particularly, to in vivo medical systems and methods.

BACKGROUND

Surgical navigation systems identify desired trajectories and paths totarget tissue or anatomy during surgeries for introducing medicalinterventional devices into the body. See, U.S. Pat. Nos. 9,042,958 and9,498,290, the contents of which are hereby incorporated by reference asif recited in full herein.

SUMMARY

Embodiments of the present invention provide methods, devices andsystems which can employ a system with a trajectory guide assembly thatcan serially and interchangeably hold either or both a fluid-filledsingle lumen guide or a fluid-filled multi-lumen guide and one or moreelongated device guides for localized placement and/or delivery ofdiagnostic or therapeutic devices or substances.

Embodiments of the present invention may be particularly suitable forintroducing therapeutic medications using an intrabody cannula, placingneuro-modulation leads, such as Deep Brain Stimulation (“DBS”) leads,implantable parasympathetic or sympathetic nerve chain leads and/or CNSstimulation leads, as well as other devices within the brain.

Embodiments of the present invention may be suitable for a number ofinterventional procedures in many locations inside the body including,but not limited to, brain, cardiac, spinal, urethral, and the like.

Embodiments of the present invention may be suitable for a number ofimage guided drug delivery procedures to intra-brain or other intra-bodytargeted locations.

Embodiments of the present invention may be suitable for a number ofimage-guided tumor removal procedures.

Embodiments of the present invention are directed to surgical navigationsystems that include a trajectory guide assembly with a base having apatient access aperture formed therein. The base is configured to besecured to the body of a patient; a yoke movably mounted to the base androtatable about a first axis. The assembly also includes a platform withan open port that is movably mounted to the yoke and rotatable about asecond axis. The system also includes a trajectory selection guidemember comprising at least one longitudinally extending fluid filledchannel of one or more contrast agents releasably attachable to theplatform; and a multi-lumen device guide comprising a plurality oflongitudinally extending open channels releasably attachable to theplatform. The trajectory selection guide member and the multi-lumendevice guide are serially interchangeably held by the platform and eachhave a length sufficient to extend through the port of the platform witha bottom portion thereof residing a distance below the platform.

The system can include an image processing circuit configured togenerate and display a virtual trajectory selection guide memberconfigured as a virtual multi-lumen guide array and aligned with animage of the trajectory guide assembly. The virtual multi-lumen guidearray can include a plurality of radially and/or circumferentiallyspaced apart virtual channels spaced apart about a virtual centerchannel in a pattern corresponding to positions of the open channels ofthe multi-lumen device guide. The virtual center channel can be alignedwith a center of the open port of the platform.

The platform can include visual orientation indicia on an upper surfacethereof that includes a patient right directional indicator, a patientleft directional indicator and a forward directional indicator.

The trajectory selection guide member can be a multi-lumen guide arraywith a plurality of radially and/or circumferentially spaced apart fluidfilled lumens spaced apart about a center fluid filled lumen. Thetrajectory selection guide member can have an upper surface with visualorientation indicia including a patient right directional indicator, apatient left directional indicator and a forward directional indicator.

The trajectory selection guide member can have a cap sealably attachedto and enclosing a primary body. The cap can reside above a liquidreservoir. The liquid reservoir can have a width that is larger than awidth of the at least one longitudinally extending fluid filled lumenand merges into the at least one longitudinally extending fluid filledchannel.

The platform can be rectangular. The system can also include a tubularsupport member held by the platform that extends under the open port.The open port of the platform can have a perimeter with an alignmentfeature that circumferentially extends about a sub-set of the perimeterand that slidably receives a matable alignment feature on themulti-lumen device guide.

The system can further include at least one drill bit guide that is alsoreleasably and interchangeably extended through the port of the platformand is directly secured to the platform. The at least one drill bitguide can be one or more of: a rotatable offset guide with alongitudinally extending channel that is offset from an axiallyextending centerline of the guide; a center guide with a longitudinallyextending channel that is centered with an axially extending centerlineof the guide; and a rotatable combination guide with a centerlongitudinally extending channel that is aligned with an axiallyextending centerline of the guide and a radially offset longitudinallyextending channel.

The trajectory selection guide member can be a multi-lumen guide arraythat comprises a plurality of radially and/or circumferentially spacedapart fluid filled lumens spaced apart about a center fluid filledlumen. The multi-lumen guide array and the multi-lumen device guide canhave the same number of channels in the same array configuration.

The virtual multi-lumen guide array and the multi-lumen device guide canhave the same number of channels in a common array configuration.

The trajectory selection guide member can be a multi-lumen guide arraywith a plurality of radially and/or circumferentially spaced apart fluidfilled lumens. The fluid filled channels of the multi-lumen guide arrayterminate at a top end under a cap. The multi-lumen device guide canhave a top end that is at the same height as the top end of the fluidfilled channels.

The trajectory guide assembly can include a pair of arcuate laterallyspaced apart arms that hold the platform therebetween and above the baseand only two actuators for pitch and roll.

The trajectory guide assembly can be devoid of x-y direction actuators.

The platform can be slidably supported by the arms to thereby allow themount to slidably travel forward and rearward over a curvilinear pathdefined by the arms.

The plurality of fluid filled channels can have a common length.

The trajectory selection guide member can be a multi-lumen guide arraywith a plurality of radially and/or circumferentially spaced apart fluidfilled lumens spaced apart about a center fluid filled lumen.

The plurality of fluid filled channels of the multi-lumen guide arrayand the plurality of open channels of the device guide can be seven.

The trajectory selection guide member can be a multi-lumen guide arraywith a plurality of spaced apart longitudinally extending fluid filledlumens. The plurality of longitudinally extending fluid filled channelscan include a center channel with adjacent channels residing spacedapart about the center channel. The multi-lumen guide array can includeorientation indicia corresponding to patient directions of right, leftand forward. The platform can have corresponding orientation indicia.

Yet other embodiments are directed to surgical navigation systems thatinclude a trajectory guide assembly comprising: a base having a patientaccess aperture formed therein. The base is configured to be secured tothe body of a patient. The assembly also includes a yoke movably mountedto the base and rotatable about an axis; and a platform with an openport that is movably mounted to the yoke and rotatable about an axis.The systems also include a trajectory selection guide comprising atleast one longitudinally extending fluid filled channel of one or morecontrast agents releasably attachable to the platform; and a multi-lumendevice guide comprising a plurality of longitudinally extending openchannels releasably attachable to the platform. The trajectory selectionguide and the multi-lumen device guide are serially interchangeably heldby the platform to extend through the port of the platform with asegment thereof residing a distance below the platform.

The system can further include an image processing circuit configured togenerate and display a virtual trajectory selection guide memberconfigured as a virtual multi-lumen guide array and aligned with animage of the trajectory guide assembly. The virtual multi-lumen guidearray can include a plurality of radially and/or circumferentiallyspaced apart virtual channels spaced apart about a virtual centerchannel in a pattern corresponding to positions of the open channels ofthe multi-lumen device guide. The virtual center channel can be alignedwith a center of the open port of the platform.

The system can further include at least one drill bit guide that is alsoreleasably and interchangeably extended through the port of the platformand is directly secured to the platform. The at least one drill bitguide can include at least one of: a rotatable offset guide with alongitudinally extending channel that is offset from an axiallyextending centerline of the guide; a center guide with a longitudinallyextending channel that is centered with an axially extending centerlineof the guide; and a rotatable combination guide with a centerlongitudinally extending channel that is aligned with an axiallyextending centerline of the guide and a radially offset longitudinallyextending channel.

The platform can include directional orientation indicia on an uppersurface thereof, wherein the trajectory guide assembly further comprisesa pair of arcuate laterally spaced apart arms that hold the platformtherebetween and above the base and only two actuators for pitch androll. The trajectory guide assembly can be devoid of x-y directionactuators.

The virtual multi-lumen guide array and the multi-lumen device guide canhave the same number of lumens in a common array configuration.

The trajectory selection guide is a multi-lumen guide array thatcomprises a plurality of radially and/or circumferentially spaced apartfluid filled lumens spaced apart about a center fluid filled lumen, andwherein the multi-lumen guide array and the multi-lumen device guidehave the same number of channels in a common array configuration.

The trajectory selection guide member can be a multi-lumen guide arraythat has a plurality of spaced apart longitudinally extending fluidfilled lumens. The fluid filled channels of the multi-lumen guide arraycan terminate at a top end under a cap. The multi-lumen device guide canhave a top end that is at the same height as the top end of the fluidfilled channels.

The plurality of longitudinally extending fluid filled channels can havea common length.

The plurality of fluid filled channels in the multi-lumen guide arrayand the plurality of open channels in the multi-lumen device guide canbe seven

The plurality of longitudinally extending fluid filled channels can havea center channel and adjacently positioned channels residing spacedapart about the center channel.

The multi-lumen device guide array can have orientation indiciacorresponding to patient directions of right, left and forward and theplatform can have corresponding orientation indicia.

Other embodiments are directed to methods of introducing a device(s)into a subject. The methods include: placing a trajectory frame on asubject, the trajectory frame comprising a base, a yoke attached to thebase and a platform attached to the yoke, the platform comprising anopen port; inserting a trajectory guide with a single longitudinallyextending fluid-filled lumen or a multi-lumen guide array with aplurality of longitudinally extending fluid filled channels through theport and securing the trajectory guide or the guide array directly tothe platform; identifying a desired trajectory; removing the trajectoryguide or the multi-lumen guide array from the platform; inserting adevice guide with multiple open longitudinally extending throughchannels into the port and securing the device guide to the platform;and introducing at least one device into a channel of the open channelsof the device guide and into a body of a subject.

The methods can also include: electronically generating a virtualmulti-lumen guide array with a plurality of longitudinally extendingparallel virtual channels; electronically aligning the generated virtualmulti-lumen guide array with an image of the trajectory frame; anddisplaying an image with the virtual multi-lumen guide array overlaid onthe trajectory frame with the virtual. The virtual multi-lumen guidearray can include a plurality of radially and/or circumferentiallyspaced apart virtual channels spaced apart about a virtual centerchannel in a pattern corresponding to positions of the open channels ofthe multi-lumen device guide.

The electronically aligning can be carried out by identifyingorientation features of the trajectory guide on the subject in Millimage data and aligning the virtual center channel with a center of theopen port of the platform.

According to some embodiments of the present invention, system has abase, a yoke movably mounted to the base and that is rotatable about aroll axis, and a platform movably mounted to the yoke and that isrotatable about a pitch axis. The platform includes a port that canreleasably and interchangeably hold a tubular single or multi-lumenfluid filled guide array member and at least one tubular device guidecomprising a plurality of longitudinally extending open lumens. The basehas a patient access aperture formed therein and is configured to besecured to the body of a patient such that the aperture overlies anopening in the body.

A roll actuator can be operably connected to the yoke and is configuredto rotate the yoke about the roll axis. A pitch actuator can be operablyconnected to the platform and is configured to rotate the platform aboutthe pitch axis.

The base may include a plurality of locations for attachment to a bodyof a patient via fasteners. In some embodiments, one or more attachmentlocations may include multiple adjacent apertures configured to receivea fastener therethrough. For embodiments where the frame is configuredto be attached to the skull of a patient, the base can be configured tobe secured to the skull of a patient such that the patient accessaperture overlies a burr hole formed in the patient skull.

According to some embodiments of the present invention, the yokeincludes a pair of spaced apart arcuate arms. The platform directlysupports the multi-lumen guide array and the multi-lumen device guideand moves along the yoke arcuate arms when rotated about the pitch axis.

The base can include at least one arcuate arm. The yoke engages andmoves along the base arcuate arm when rotated about the roll axis.

In some embodiments, the actuators are color-coded such that eachdifferent actuator has a respective different color. This allows a userto quickly determine which actuator is the correct one for a particulardesired movement of the frame.

The elongated tubular guide extends through the port in the platform andyoke along a Z-direction and includes opposite proximal and distal endportions. The device guide distal end portion is positioned proximatethe patient access aperture. The device guide includes a boretherethrough that extends from the proximal end portion to the distalend portion, and the device guide can be configured to removably receivedifferent devices within one or more open bores. The devices may havedifferent sizes and configuration. Exemplary devices include a needleinfusion cannula, a tracking device with an array of optical fiducials,a microelectrode drive, a catheter guide, etc.

The at least one tubular device guide can include a multi-lumen deviceguide with a plurality of parallel longitudinally extending openthrough-lumens.

In some embodiments of the present invention, the at least one deviceguide can have a proximal end portion which engages the platform overthe port. For example, the device guide proximal end portion may includea detent, or other type of structure (shape and/or component), formedtherein, for a quick-release attachment.

The device guide can include a portion having a protrusion configured toengage the detent so as to removably secure the device to the guide viaa snap fit. Alternatively, the guide proximal end portion may include aprotrusion and the device may include a portion having a detent formedtherein that is configured to engage the protrusion so as to removablysecure the device to the guide via a snap fit.

The term “quick release,” as used herein, means that a technician orother user can quickly (e.g., typically in under about 1 minute or underabout 30 seconds) remove a device from the guide with little effort andwithout requiring tools.

According to some embodiments of the present invention, aninterventional method includes affixing a frame with a cooperatingsingle lumen or multi-lumen fluid filled array to the skull of apatient, identifying a desired trajectory, replacing the single lumen ormulti-lumen fluid filled array with a device guide.

The method may be carried out in an operating room using a camera basedtracking system.

The method may be carried out using images acquired from a CT scannerduring the procedure and/or using MRI images.

In some embodiments, such as, for neuro, using both pre-acquired andreal time acquired MRI brain images and CT images at one or times duringthe procedure).

The entire workflow of a patient procedure may be carried out entirelyin an Mill suite or in an OR followed by an MRI suite.

It is noted that aspects of the invention described with respect to oneembodiment may be incorporated in a different embodiment although notspecifically described relative thereto. That is, all embodiments and/orfeatures of any embodiment can be combined in any way and/orcombination. Applicant reserves the right to change any originally filedclaim or file any new claim accordingly, including the right to be ableto amend any originally filed claim to depend from and/or incorporateany feature of any other claim although not originally claimed in thatmanner. These and other objects and/or aspects of the present inventionare explained in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side perspective view of an example stylus of a surgicalnavigation system that can be used to provide an entry into a patient.

FIG. 1B is a schematic side perspective view of the example stylus shownin FIG. 1A used to pick an entry point into a skull of a patient.

FIG. 2A is a side perspective view of an example centering screw guidethat can directly anchor over a selected entry point on a patient, i.e.,patient skull, for a twist point entry sequence, according toembodiments of the present invention.

FIG. 2B is a top, side perspective view of a screw driver that can beused to secure the centering screw guide shown in FIG. 2A to a patientaccording to embodiments of the present invention.

FIG. 2C is a top, side perspective view of the centering screw guideshown in FIG. 2A with the screw secured into the skull according toembodiments of the present invention.

FIG. 2D is a top perspective view of a centering tool that can cooperatewith the centering guide screw to help position a trajectory frame ontothe patient according to embodiments of the present invention.

FIG. 2E is a top perspective view of the centering tool shown in FIG. 2Dconcentrically positioned about and attached directly onto the centeringscrew guide according to embodiments of the present invention.

FIG. 2F is a top perspective vie of the centering tool that can bedirectly placed into a divot formed by a burr hole entry (instead of atwist point entry and not requiring a centering guide screw) accordingto embodiments of the present invention.

FIG. 2G is a side perspective view of the centering tool positioned sothat a distal end thereof fits directly into the burr hole according toembodiments of the present invention.

FIG. 3A is a side perspective view of an example trajectory frame basethat can couple to a patient's skull or other target device or anatomyaccording to embodiments of the present invention.

FIG. 3B is a side perspective view of the trajectory frame base alignedover the centering tool shown in FIGS. 2D and 2G according toembodiments of the present invention.

FIG. 3C illustrates the trajectory frame base secured to the patient andthe centering guide removed according to embodiments of the presentinvention.

FIGS. 4A and 4B are side perspective views of an example trajectoryframe that can be attached to the base shown in FIG. 3A according toembodiments of the present invention.

FIG. 4C is a partially exploded view of the trajectory frame shown inFIGS. 4A and 4B.

FIG. 4D is a side perspective view of the trajectory frame aligned withthe base according to embodiments of the present invention.

FIG. 4E is a side perspective assembled view of the trajectory frame andbase according to embodiments of the present invention.

FIG. 5A a side perspective view of the trajectory frame and base and anavigation stylus adapter that is releasably held by the trajectoryframe according to embodiments of the present invention.

FIG. 5B is an assembled view of the navigation stylus adapter in thetrajectory frame shown in FIG. 5A.

FIG. 5C is a top perspective view of a navigation stylus insertable intothe adapter shown in FIG. 5B according to embodiments of the presentinvention.

FIG. 5D is an assembled view of the components shown in FIG. 5C.

FIG. 5E is an enlarged side view of the assembled device shown in FIG.5C illustrating a pitch adjustment actuator for pitch adjustmentsaccording to embodiments of the present invention.

FIG. 5F is a side perspective view of the assembled device shown in FIG.5C illustrating an example pitch adjusted orientation according toembodiments of the present invention.

FIG. 5G is an enlarged side view of the assembled device shown in FIG.5C illustrating a roll adjustment actuator for roll adjustmentsaccording to embodiments of the present invention.

FIG. 511 is a side perspective view of the assembled device shown inFIG. 5C illustrating an example roll-adjusted orientation according toembodiments of the present invention.

FIG. 6A is a side perspective view of an example guide array with fluidfilled lumens according to embodiments of the present invention.

FIG. 6B is a top view of a primary body of the guide array shown in FIG.6A.

FIG. 6C is a side partial exploded view of the guide array shown in FIG.6A.

FIG. 6D is side perspective view of the guide array shown in FIG. 6Awith internal fluid filled lumen channels shown partially transparent.

FIG. 7A is a side perspective view of the guide array aligned with thetrajectory frame for assembly thereto according to embodiments of thepresent invention.

FIG. 7B is an enlarged side perspective view of the guide array in theplatform of the trajectory guide according to embodiments of the presentinvention.

FIG. 7C is a side perspective assembled view of the components shown inFIG. 7A.

FIGS. 7D and 7E are partial top views of the assembly shown in FIG. 7C.

FIG. 8 is a side view of a fluid-filled guide array adjacent amulti-lumen guide according to embodiments of the present invention.

FIGS. 9A-9C are top, side perspective views of example device guidesaccording to embodiments of the present invention.

FIG. 10A is a top, side perspective views of the device guide shown inFIG. 9C aligned with the trajectory frame according to embodiments ofthe present invention.

FIG. 10B illustrates the device guide shown in FIG. 10A assembled to thetrajectory frame.

FIGS. 10C and 10D are top views of the assembly shown in FIG. 10Baccording to embodiments of the present invention.

FIG. 10E is a top view of an example user interface providing rotationalalignment feedback of a desired orientation of the guide channel to auser according to embodiments of the present invention.

FIG. 10F is a partial side perspective view of a drill and drill bitcooperating with the device guide and trajectory frame assembly shown inFIG. 10B according to embodiments of the present invention.

FIG. 10G is a side perspective view of the drill and drill bit shown inFIG. 10F prior to coupling to the device guide according to embodimentsof the present invention.

FIG. 10H is a top perspective view of the trajectory frame after thedevice guide shown in FIG. 10B is removed with a twist point entry holemade using the drill and drill bit shown in FIG. 10G.

FIGS. 11A and 11B are side perspective views of an example multi-lumenguide with open through channels according to embodiments of the presentinvention.

FIG. 11C is a top view of the device shown in FIGS. 11A and 11Balongside a fluid-filled guide according to embodiments of the presentinvention.

FIG. 11D is a top perspective view of the multi-lumen guide shown inFIGS. 11A and 11B aligned with the trajectory frame according toembodiments of the present invention.

FIG. 11E is an assembled view of the components shown in FIG. 11D.

FIG. 11F is a side perspective view of an example therapeutic devicealigned with the assembled components shown in FIG. 11F according toembodiments of the present invention.

FIG. 11G illustrates the therapeutic device held by the multi-lumenguide and trajectory frame shown in FIG. 11F.

FIGS. 12A and 12B are partial side perspective assembled views of theassembled components shown in FIG. 11E and illustrating a singletherapeutic device coupled thereto (FIG. 12A) and multiple therapeuticdevices coupled thereto (FIG. 12B) according to embodiments of thepresent invention.

FIG. 13A is an enlarged top perspective view of an exemplary grid thatcan be used to select an entry point according to embodiments of thepresent invention.

FIG. 13B is a top, side perspective view of the grid shown in FIG. 13Aused with a centering screw guide and screwdriver according toembodiments of the present invention.

FIG. 13C illustrates the centering guide coupled to the grid accordingto embodiments of the present invention.

FIG. 13D illustrates a bone screw coupled to the grid according toembodiments of the present invention.

FIG. 13E illustrates an enlarged view of the bone screw in position withthe grid removed according to embodiments of the present invention.

FIG. 14A is an enlarged partial section view of an example targetingcannula according to embodiments of the present invention.

FIG. 14B is a side perspective view of the targeting cannula shown inFIG. 14A aligned with the trajectory frame shown in FIG. 4E according toembodiments of the present invention.

FIGS. 14C and 14D are side perspective assembled views of the componentsshown in FIG. 14B.

FIGS. 14E and 14F are side views illustrating example pitch adjustmentsusing the targeting cannula and trajectory frame shown in FIG. 14B.

FIGS. 14G and 14H are side views illustrating example roll adjustmentsusing the targeting cannula and trajectory frame shown in FIG. 14B.

FIG. 15A is a schematic illustration of a surgical navigation systemthat uses a virtual guide array according to embodiments of the presentinvention.

FIG. 15B is a top view of a trajectory frame with a multi-lumen guideaccording to embodiments of the present invention.

FIG. 16 is a flow chart of exemplary actions that can be used for amedical procedure according to embodiments of the present invention.

FIG. 17 is a block diagram of a data processing system according toembodiments of the present invention.

DETAILED DESCRIPTION

The present invention now is described more fully hereinafter withreference to the accompanying drawings, in which some embodiments of theinvention are shown. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

Like numbers refer to like elements throughout. In the figures, thethickness of certain lines, layers, components, elements or features maybe exaggerated for clarity. The terms “Fig.” and “FIG.” may be usedinterchangeably with the word “Figure” as abbreviations thereof in thespecification and drawings.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising”, when used in this specification, specify thepresence of stated features, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, steps, operations, elements, components, and/or groupsthereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

It will be understood that when an element is referred to as being “on”,“attached” to, “connected” to, “coupled” with, “contacting”, etc.,another element, it can be directly on, attached to, connected to,coupled with or contacting the other element or intervening elements mayalso be present. In contrast, when an element is referred to as being,for example, “directly on”, “directly attached” to, “directly connected”to, “directly coupled” with or “directly contacting” another element,there are no intervening elements present. It will also be appreciatedby those of skill in the art that references to a structure or featurethat is disposed “adjacent” another feature may have portions thatoverlap or underlie the adjacent feature.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if the device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of “over” and “under”. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

The term “about”, as used herein with respect to a value or number,means that the value or number can vary by +/− twenty percent (20%).

The term “MRI visible” means that a device is visible, directly orindirectly, in an MRI image. The visibility may be indicated by theincreased SNR of the MRI signal proximate to the device (the device canact as an MRI receive antenna to collect signal from local tissue)and/or that the device actually generates MRI signal itself, such as viasuitable hydro-based coatings and/or fluid (typically aqueous solutions)filled channels or lumens.

The term “MRI compatible” means that a device is safe for use in an MRIenvironment and/or can operate as intended in an MRI environment withoutgenerating MR signal artifacts, and, as such, if residing within thehigh-field strength region of the magnetic field, is typically made of anon-ferromagnetic MRI compatible material(s) suitable to reside and/oroperate in a high magnetic field environment.

The term “high-magnetic field” refers to field strengths above about0.5T (Tesla), typically above 1.0T, and more typically between about1.5T and 10T.

The term “targeting cannula” refers to an elongate device, typicallyhaving a substantially tubular body that can be oriented to providepositional data relevant to a target treatment site and/or define adesired access path orientation or trajectory. At least portions of atargeting cannula contemplated by embodiments of the invention can beconfigured to be visible in an MRI image, thereby allowing a clinicianto visualize the location and orientation of the targeting cannula invivo relative to fiducial and/or internal tissue landscape features.

The term “cannula” refers to an elongate device that can be associatedwith a trajectory frame that attaches to a patient, but does notnecessarily enter the body of a patient.

The term “imaging coils” refers to a device that is configured tooperate as an MRI receive antenna. The term “coil” with respect toimaging coils is not limited to a coil shape but is used generically torefer to MRI antenna configurations, loopless, looped, etc., as areknown to those of skill in the art. The term “fluid-filled” means thatthe component includes an amount of the fluid but does not require thatthe fluid totally, or even substantially, fill the component or a spaceassociated with the component. The fluid may be an aqueous solution, MRcontrast agent, CT contrast material or any material that generates asignal in the imaging modality used.

The term “two degrees of freedom” means that a trajectory framedescribed herein allows for at least translational (swivel or tilt) androtational movement over a fixed site, which may be referred to as aRemote Center of Motion (RCM).

The terms “ACPC coordinate space” or “AC-PC orientation” refers to aright-handed coordinate system defined by anterior and posteriorcommissures (AC, PC) and Mid-Sagittal plane points, with positivedirections corresponding to a patient's anatomical Right, Anterior andHead directions with origin at the mid-commissure point.

Embodiments of the present invention can be configured to guide and/orplace diagnostic or interventional devices and/or therapies to anydesired internal region of the body or object using MRI and/or in an MRIscanner or MRI interventional suite or using other image guided systemsnot requiring an MRI system or suite.

The object can be any object, and may be particularly suitable foranimal and/or human subjects. Some embodiments can be sized andconfigured to place implantable DBS leads for brain stimulation,typically deep brain stimulation. Some embodiments can be configured todeliver tools or therapies that stimulate a desired region of thesympathetic nerve chain. Other uses inside or outside the brain includestem cell placement, gene therapy or drug delivery for treatingphysiological conditions. Some embodiments can be used to treat tumors.Some embodiments can be used for RF ablation, laser ablation, cryogenicablation, etc.

In some embodiments, the trajectory frame and/or interventional toolscan be configured to facilitate high resolution imaging via integralintrabody imaging coils (receive antennas), high intensity focusedultrasound (HIFU), and/or the interventional tools can be configured tostimulate local tissue, which can facilitate confirmation of properlocation by generating a physiologic feedback (observed physicalreaction or via fMRI).

Some embodiments can be used to deliver bions, stem cells or othertarget cells to site-specific regions in the body, such as neurologicaltarget sites and the like. In some embodiments, the systems deliver stemcells and/or other cardio-rebuilding cells or products into cardiactissue, such as a heart wall via a minimally invasive image guidedprocedure, while the heart is beating (i.e., not requiring a non-beatingheart with the patient on a heart-lung machine). Examples of knownstimulation treatments and/or target body regions are described in U.S.Pat. Nos. 6,708,064; 6,438,423; 6,356,786; 6,526,318; 6,405,079;6,167,311; 6539,263; 6,609,030 and 6,050,992, the contents of which arehereby incorporated by reference as if recited in full herein.

Generally stated, some embodiments of the invention are directed tointerventional procedures and provide interventional tools and/ortherapies that may be used to locally place interventional tools ortherapies in vivo to site-specific regions using an image guided system.The interventional tools can be used to define a trajectory or accesspath to an in vivo treatment site. Some embodiments of the inventionprovide interventional tools that can provide positional data regardinglocation and orientation of a tool in 3-D space with a visualconfirmation on an image. Embodiments of the invention may provide anintegrated system or trajectory frames and components that can be usedwith one or more of commercially available conventional image guidedsystems that may allow physicians to place interventional devices/leadsand/or therapies accurately.

Some embodiments configure devices so that they are compatible withseveral imaging modalities and/or image-guided systems.

For MRI uses, the systems may allow for shorter duration procedures overconventional systems (typically under six hours for DBS implantationprocedures, such as between about 1-5 hours).

In some embodiments, a pre-operative image such as an MRI image can beused to visualize (and/or locate) a therapeutic region of interestinside the brain or other body locations. During surgery, the MRI orother pre-operative image can be used to visualize (and/or locate) aninterventional tool or tools that will be used to deliver therapy and/orto place a chronically implanted device that will deliver therapy.

Embodiments of the invention provide devices and an operational sequenceof a procedure that can be initiated in a first operating room thencompleted in a second operating room such as an MRI suite according tosome embodiments of the present invention.

The same trajectory frame 100 can serially releasably hold a trajectoryguide member that can have at least one elongate, longitudinallyextending, fluid filled lumen, i.e., a single fluid filled lumen or maybe configured as a multi-lumen fluid filled guide array, andinterchangeable elongate device guides which can have one or multiplethrough/open lumens as will be discussed below. In some embodiments, anentire surgical procedure can be carried out in the Operating Room (OR)not requiring the use of an MRI suite using some of the devices shown.

In some embodiments, the three-dimensional data produced by a CT-guidedand/or MRI-guided interventional system regarding the location of thetherapeutic region of interest and the location of the interventionaltool can allow the system and/or physician can make positionaladjustments to the interventional tool so as to align the trajectory ofthe interventional tool with the region of interest, so that wheninserted into the body, the interventional tool will intersect with thetherapeutic region of interest.

In some embodiments, a camera based tracking system can be used.

The systems can have a hardware component(s) and a softwarecomponent(s). In some embodiments, the hardware component includes acamera and workstation that can be used for many applications such ascranial, spine, orthopedic, ENT. There can be different softwarepackages or modules for each system and/or for each application.

When the imaging system and/or the camera based image guided systemconfirms alignment is proper, the interventional tool aligned with thetherapeutic region of interest, an interventional probe can be advanced,such as through an open lumen inside of the interventional tool, so thatthe interventional probe follows the trajectory of the interventionaltool and proceeds to the therapeutic region of interest. It should benoted that the interventional tool and the interventional probe may bepart of the same component or structure. A sheath may optionally formthe interventional tool or be used with an interventional probe or tool.

In particular embodiments, using MRI in combination with local orinternal imaging coils and/or MRI contrast material that may becontained at least partially in and/or on the interventional probe orsheath, the location of the interventional probe within the therapeuticregion of interest can be visualized on a display or image and allow thephysician to either confirm that the probe is properly placed fordelivery of the therapy (and/or placement of the implantable device thatwill deliver the therapy) or determine that the probe is in theincorrect or a non-optimal location. Assuming that the interventionalprobe is in the proper desired location, the therapy can be deliveredand/or the interventional probe can be removed and replaced with apermanently implanted therapeutic device at the same location.

Although described and illustrated herein with respect to the brain andthe insertion of deep brain stimulation leads, it is understood thatembodiments of the present invention may be utilized at other portionsof the body and for various other types of procedures.

The image-guided system can be used for MRI and/or non-MRI image guidedsystems.

The trajectory frame and some or all of its cooperating components maybe configured to be compatible for use in MRI and CT and/or camera basedimage guided systems.” To be clear, the term “image guided system” isused generally to refer to surgical navigation systems that includedisplays with patient images (which may be acquired before a surgeryand/or at defined points during a surgery to confirm location) but doesnot require a continuous series of images from an imaging modality, suchas a CT or MRI scanner, during the surgery.

In some embodiments, the system can include or work with a trajectoryguide software module that can be an off-the-shelf module provided withconventional image guided systems that does not require any (orinsignificant) modification. Examples of known commercial systems withtrajectory guide software modules for camera based image guided systemsthat can be used with configurations of the trajectory frames andcooperating components include, for example systems from Brainlab, Inc.,Stryker Medical and Medtronic Inc.

Referring to FIGS. 1A and 1B, a navigation stylus 5 can be used to finda pre-planned trajectory and intrabody entry point, such as an entrypoint Se into a skull S of a patient. The stylus 5 is shown by way ofexample only and can have other shapes and configurations. The stylus 5can be part of an OR navigation system used outside an MRI suite. Thereare two primary (or at least preferred) options for a surgeon to use tocreate an entry point Se into a brain through a skull. Option 1 is touse a twist point drill to create a small access hole typically in arange of about 2 mm to about 6.0 mm, such as about 3.4 mm, about 4.5 mmand about 6.0 mm. Option 2 is to create a larger burr hole such as aburr hole in a range of bout 10-mm to about 15 mm, such as about 14 mm.

FIGS. 2A-2E illustrate the use of a centering screw guide 10 that can bedirectly attached to a patient at the selected entry point Se via ascrew driver 15 for Option 1. FIG. 2D illustrates a centering tool 18can be posited onto the centering screw guide 10. The centering tool 18can enter a base 110 that can support a trajectory frame 100 (FIG. 4A).The term “trajectory frame” is used interchangeably with “trajectoryguide assembly.” The centering tool 18 can fit concentrically onto andover the centering screw guide 10 as shown in FIG. 2E.

FIGS. 2F and 2G illustrate that the centering tool 18 can fit directlyinto a burr hole Sb formed by Option 2. The burr hole Sb can have adiameter in a range of about 10 mm-15 mm, such as about 14 mm, and canbe formed through the skull based on a smaller divot made by thenavigation stylus 5 (FIG. 1A). A distal end 18 d of the centering tool18 can fit directly into the burr hole Sb.

FIG. 3A illustrates an example trajectory frame base 110 that can beused to anchor to the patient's skull. The base 110 can be a scalp mountbase with a plurality of bone screws 113 and a plurality of stand-offpins 114. This configuration uses a minimal incision over the entrypoint Se to create the access. Other trajectory frame bases can be usedincluding, for example, a skull mount base which uses a larger incisionand can mount directly to the skull but requires the scalp to beretracted for the direct skull attachment (not shown). FIG. 3Billustrates the base aligned with the centering tool 18 that is attachedto the centering screw guide 10. A distal end of the base 110 can have aport 112 that fits concentrically about the centering tool 18. As shownin FIG. 3C, once the base 110 is secured to the patient, the centeringtool 18 can be removed (as well as the centering screw guide 10, ifused).

Referring to FIGS. 4A-4E, 7A-12B, a trajectory frame 100 is shown. Theupper portion 100 u of the trajectory frame 100 can be attached to thebase 110 after the base 110 is secured to the patient. The base 110 canbe affixed to the trajectory frame 100 via fixation screws 122 (FIG.4D).

Generally stated, the trajectory frame 100 may be configured toreleasably and interchangeably (serially) hold different devices suchas, for example, a fluid-filled single lumen guide 111 (FIGS. 14A-14C)which may also be referred to as a “targeting cannula” and/or amulti-lumen guide array 211 (FIGS. 6A-6E) and at least one device guide311 (FIG. 8). The guides 111 and 211 can also be referred to as atrajectory selection guide member.

Referring to FIGS. 4A-4E, the trajectory frame 100 can include a tubularmember 204, such as a tower or column, that is held by the platform andthat extends a distance below the platform 132. The platform 132 can beplanar and have an open port 132 p that removably and interchangeably(serially) receives one or more of the single fluid-filled lumen guide111 (FIGS. 17A-17C), the fluid-filled guide array 211 and one or moredifferent device guides 311 (FIGS. 11A-12B) and optionally one or moredrill guides 1311 (FIG. 9) that have open lumens. The planar platform132 can be rectangular and held by arcuate arms 101 of the trajectoryframe 100. The planar platform 132 can have orientation indicia 132 i(FIG. 7E) on a top surface thereof. In some embodiments, the deviceguide 311 can have the same number and configuration of lumens as thefluid-filled guide array 211 (FIGS. 8, 11C).

The tubular member 204 can define a Z-direction along its longitudinalaxis relative to the X-Y plane of the platform 132 (which does notinclude an X-Y table).

Referring to FIGS. 4C and 4D, the yoke 120 is movably mounted to thebase 110 and is rotatable about a roll axis. A roll actuator 140 b isoperably connected to the yoke 120 and is configured to rotate the yoke120 about the roll axis. In some embodiments, the yoke 120 has a rangeof motion about the roll axis of about seventy degrees (70°). However,other ranges, greater and lesser than 70°, are possible, e.g., anysuitable angle typically between about 10°-90°, 30°-90°, etc. Theillustrated platform 132 is movably mounted to the yoke 120 and isrotatable about a pitch axis. A pitch actuator 140 a is operablyconnected to the platform 132 and is configured to rotate the platform130 about the pitch axis. In some embodiments, the platform 132 has arange of motion about the pitch axis of about seventy degrees (70°).However, other ranges, greater and lesser than 70°, are possible, e.g.,any suitable angle typically between about 10°-90°, 30°-90°, etc.

The base 110 also includes a pair of spaced apart arcuate arms 116, asillustrated in FIG. 4D. The yoke 120 engages and moves along the basearcuate arms 116 when rotated about the roll axis. In the illustratedembodiment, one of the base arcuate arms 116 includes a thread pattern118 formed in (e.g., embossed within, machined within, etc.) a surface116 a thereof. However, in other embodiments, both arms 116 may includerespective thread patterns.

One or both actuators 140 a, 140 b can include a rotatable worm gear(i.e., worm 121, FIG. 4C) with teeth that are configured to engage athread pattern. As the worm gear is rotated, the teeth travel along thethread pattern in the arcuate arm surface.

Referring to FIG. 4D, for example, the trajectory frame 100 includes abase 110, a yoke 120 with the arcuate arms 101, the platform 130, andonly two actuators 140 a-140 b, which are pitch and roll actuators. Nox-y actuators are provided in this embodiment. The base 110 has apatient access aperture 112 formed therein, as illustrated. The base 110is configured to be secured (directly or indirectly) to the skull of apatient such that the patient access aperture 112 overlies a burr holein the patient skull. The patient access aperture 112 can be centeredover the burr hole via the removable centering device 18 as discussedabove (FIG. 2D).

Referring to FIGS. 5A-5H, the trajectory frame 100 can releasably hold anavigation stylus adapter 25. A fixation screw 133 in the platform 132can tighten against the adapter 25. The navigation stylus adapter 25 cansecure the navigation stylus 5 such that it is concentrically alignedwith the port 132 p and used to make trajectory adjustments. The stylus5 can be inserted into the stylus adapter 25 until it bottoms out insidethe adapter 25 (i.e., it does not extend outside the bottom end of theadapter 25). A fixation screw 134 on an upper end portion of the adapter5 can then be tightened against the stylus 5.

FIGS. 5E and 5F illustrate pitch adjustments (which can be clockwise orcounterclockwise) via pitch actuator 140 a and FIGS. 5G and 5Hillustrate roll adjustments via roll actuator 140 b (which can beclockwise or counterclockwise).

Referring to FIGS. 4B, 5A and 5C, the stylus 5 can have a length L₁(FIG. 5C) that is much greater than the length L₂ of the tubular(support) member 204 and the stylus adapter 25. The tubular member 204can have a length L₂ (FIG. 4B) that is greater than the length L₃ (FIG.5A) of the stylus adapter 25. L₁ can be 3×-20× greater than L₂, in someembodiments, more typically 4×-8× greater.

Once the trajectory alignment is complete (the trajectory defined by thetrajectory guide frame 100 and stylus 5 are approved by a surgeon), thepatient can be moved from the OR to a surgical room which may be an Millsuite for further steps in a procedure/further treatment.

Referring to FIGS. 6A-6E, after a trajectory is selected/set, a CTand/or MRI visible fluid filled guide 211 can be secured to thetrajectory frame 100 (after stylus adapter 25, where used, is removed)and be used to pick a path to the target. In some embodiments, thefluid-filled guide 211 can provide a plurality of selectable paths, eachpath associated with a straight linear and (MR visible) fluid filledlumen 211 f defined by the guide array 211 to give a surgeon multipleoptions for selecting a safe path to the desired target. In otherembodiments, the fluid filled guide can provide a single fluid filledlumen. The multiple paths can allow a surgeon to select a path from oneof the plurality of paths associated with the lumens 211 f tocounter-act any mounting errors. The fluid-filled guide 211 can have acap 211 c threadably or otherwise sealably attached to the primary body211 b of the guide array. The cap 211 c can include an O-ring 211 o toprevent or inhibit leakage of fluid from the lumens 211 f, once filledwith an MRI and/or CT visible fluid.

As shown in FIGS. 6D and 6E, there can be a plurality of closely spacedapart fluid filled lumens 211 f, typically in a range of 4-10, shown as7. Where multiple fluid filled lumens are provided, the guide 211 can bereferred to as a “guide array.” The guide 211 can include channels asdirectional indicators 211 i, shown as patient left DL (single), forwardDF (single), patient right DR (dual). The directional indicator channels211 i can have a more shallow depth, shorter length and/or different(i.e., smaller or larger) cross-sectional size than the one or morefluid filled lumens 211 f.

As discussed above, the fluid filled guide 211 can have orientationindicia 211 i as shown in FIGS. 7D and 7E, shown with four spaced apartindicia with two orientation channels 211 i being closer than the othertwo. The platform 132 can have visual orientation indicia 132 i thatcorresponds to that of the guide 211 i, shown as D_(L), DF and D_(R).The indicia 211 i, 132 i can include two adjacent indicia for a patientright directional indicator, one for a patient left directionalindicator and one for a forward directional indicator, for example. Theorientation indicia 132 i on the platform 132 can be painted, coated orotherwise provided with color-coded markings on an upper surface 132 uof the platform 132 that can help a user to align the guide 211 and/oridentify a channel and/or path selection.

Referring to FIG. 7A, for example, the open port 132 p can optionally beoff center over the arcuate arms 101 to reside closer to one short side132 s of the platform 132 and can be centered side to side with respectto the long sides 132 l of the platform.

Referring to FIG. 7A, the platform 132 engages and moves along the yokearcuate arms 101 when rotated about the pitch axis. In the illustratedembodiment, one of the yoke arcuate arms 101 includes a thread pattern101 t formed in (e.g., embossed within, machined within, etc.). However,in other embodiments, both arms 101 may include respective threadpatterns.

FIGS. 7A-7E show the guide 211 attached to the trajectory frame/guide100. The guide array 211 can be locked and secured to the trajectoryframe via the fixation screw 133 of the platform 132 that was discussedabove as used to secure the stylus adapter 25. As shown in FIGS. 7A and7B, the guide 211 can have an external alignment feature 213 thatengages a mating alignment feature 139 in the platform 132 of thetrajectory frame 100 to facilitate correct orientation upon assembly. Asshown, the alignment feature 213 is a projecting ledge while the matingfeature is an enlarged perimeter segment of the port 132. However, otheraffirmative alignment configurations may be used.

Referring to FIG. 8, the device guide 311 can have lumens 312 that areopen channels and a height H that is less than that of the fluid filledguide 211. The fluid filled lumens 211 f can have a top 211 f _(t) thatis under a cap 211 c (which can also be referred to as a bottom of areservoir under the cap 211 c) and can be at the same height dimension Has the top 311 t of the multi-lumen device guide 311. The fluid filledguide 211 can be used to identify and/or select a trajectory to theintrabody target. This same trajectory can be used for introducing amedical device (1000, FIG. 11F) using the device guide 311, whichreplaces the multi-lumen guide array 211 held by the trajectory frame100. A line can be electronically drawn from the intrabody target up adesired trajectory along one of the fluid filled lumens 211 f to the topof the fluid filled channel 211 f _(t) of the fluid-filled guide array211. The distance between the intrabody target and a bottom of thereservoir/top of the fluid filled channel 211 f _(t) can be a deviceinsertion depth of a medical device 1000 (FIG. 11F).

Once the fluid-filled guide 211 is in position in the trajectory frame100, a clinician can perform an MRI scan that encompasses an imagevolume of the trajectory frame 100 and a desired intrabody target. Thefluid filled guide channel(s)/lumen(s) 211 f will be bright lines in anMRI image. A surgeon can select a fluid filled lumen 211 f that mostclosely aligns or matches the desired insertion path. The clinician(i.e., surgeon) can electronically cause the surgical system toprogrammatically calculate and/or measure a device insertion depth usingmeasurement software. That is, a line can be drawn from the target upthe desired trajectory along a selected fluid filled lumen(s) 211 f, tothe bottom of the reservoir 211 r _(b) and/or top of the fluid filledlumen 211 f _(t). The distance between the target and the bottom of thereservoir 211 rb/top of the fluid filled lumen 211 f _(t). can be usedto calculate the device insertion depth.

If a user has opted to create a smaller entry hole with a twistpointdrill then a twist point entry sequence can be followed as shown inFIGS. 10A-10H, followed by use of a device guide 311 with thelongitudinally extending open through channels 312 (FIGS. 11A-11E). If aburr hole entry was performed, there is no requirement for use of atwist point entry guide (1311, FIGS. 9A-9C) and a user can remove thefluid filled guide 211 and exchange it with the device guide 311 (FIGS.11A-11E) which is then used to insert the medical device 1000 (FIGS.11F, 11G). The user can perform the trajectory selection steps with thefluid-filled array 211 for a burr hole procedure, to pick a safe path toinsert a device through the brain. This can be carried out beforeswapping the fluid-filled guide 211 with a device guide 311.

Referring to FIGS. 9A-9C, a device guide 1311 can be inserted into thetower of the trajectory guide 100. The device guide 1311 is sized andconfigured to hold a drill bit 300 (FIGS. 10F, 10G) for a twist drill310 (FIGS. 10F, 10G). Typically, the inner diameters of the channels1312 can be about 3.4 mm, about 4.5 mm, about 6.0 mm and about 9.0 mm.The center guide 1311 c may have a channel 1312 with a larger innerdiameter. The rotatable combination guide 1311 c can be configured withthe first channel 1312 ₁ having a larger diameter than the secondchannel 1312 ₂. The larger size channel can be the center channel. Thefirst and second channels 1312, can, in some embodiments include a 3.4mm inner diameter channel and a 4.5 mm inner diameter channel. Otherdevice guides can be used with other configurations to support drillbits or larger sized therapeutic devices. A multi-lumen device guide 311suitable for smaller size devices is shown in FIGS. 11A-11E.

FIG. 9A illustrates a center guide 1311 c with a longitudinallyextending guide channel 1312 centered side to side (laterally), i.e.,centered with a longitudinally extending/axially extending center line.FIG. 9B illustrates an offset device guide 1311 o as the device guide1311. The offset device guide 1311 o is a rotatable guide with a guidechannel 1312 that is laterally offset from a longitudinallyextending/axially extending center line. FIG. 9C illustrates acombination guide 1311 m, that can include first and second guidechannels 1312, that are longitudinally extending and adjacent eachother, one of which can be centered and one of which can be laterallyoffset from center.

FIG. 10A is a top, side perspective views of the device guide 1311(shown by way of example with device guide 1311 c) aligned with thetrajectory frame 100 according to embodiments of the present invention.FIG. 10B illustrates the device guide 1311 assembled to the trajectoryframe 100 and rotationally locked into position using fixation member133.

Referring to FIGS. 10A-10D, of a surgeon decides that an offset holeshould be created, then the offset guide 1311 o (FIG. 9B) or thecombination guide 1311 m (as shown) can be rotated and locked to adesired offset position to create the entry hole St (FIG. 1011). If nooffset is needed, the center guide 1311 c or the combination guide 1311m can be used.

As shown in FIG. 10E, a surgical (navigation) system 1400 can include animage processing circuit 1600 in communication with a display 1610. Theimage processing circuit 1600 can generate an image 1500 that aligns thetrajectory frame 100 and device guide 1311 and visually illustrates adesired fluid filled channel 211 f that is the one that should be usedfor alignment 211 fa. This alignment channel 2111 fa can be highlighted,colored, darkened or otherwise visually distinguished from other fluidfilled channels 211 f. Thus, the image 1500 can include a virtualrepresentation 1211 of the guide array 211 with the selected channel 211f previously identified for the selected trajectory visuallydistinguished. The guide 1311 can be rotated to align the guide channel1312 with the visually distinguished channel 211 fa. The visuallydistinguished channel 211 fa can be displayed in a first color differentfrom one or other colors of other fluid filled lumens, or shown in blackor white while the other fluid channels 211 f are displayed in adifferent color or in black when the alignment channel 211 fa is shownin white or in white when the alignment channel 211 fa is shown inblack.

The surgeon can use the image 1500, typically an MRI image or avisualization, to display one or more fluid filled guide channel(s) 211f (virtually as the actual guide 211 is not on the trajectory frame 100during this action) and directional channels 211 i along with thealignment indicia 132 i on the platform 321 to determine which directionto rotate and by how much. When the guide 1311 is rotated to anorientation that aligns one of the channels 1312 with a pre-selectedtrajectory associated with one of the one or more fluid filled lumens211 f of the fluid-filled guide 211, the device guide 1311 can be lockedinto position using fixation member 133.

Referring to FIGS. 10C and 10D, the platform 132 can include straightoutwardly extending lines 135 on an upper surface thereof that arecircumferentially spaced apart and extend radially out from the port 132p. At least some (i.e., the longer lines) or each of the lines 135 canextend radially outward from a position of a respective fluid filledguide channel 211 f that has a fixed rotational orientation in theplatform 132. The guide device 1311 can have a radially extendingstraight line 1313 that is aligned with a laterally extending centerlineof the channel 1312. This line 1313 can align with one of the lines 135to help identify a fluid filled guide channel 211 f. This line 1313 canalign with one of the lines 135 to help position the device guidechannel 1312 over the trajectory the user has previously selected fromthe fluid-filled array channel 211 f.

FIGS. 10F and 10G show a drill 310 and drill bit 300 cooperating withthe device guide 1311 and trajectory frame 100. The drill bit 300 can beinserted into the guide channel 1312 of the device guide 1311 and thedrill 310 can be actuated to form the entry hole St as shown in FIG.10H.

FIGS. 11A-11C illustrate that a multi-lumen guide 311 with a pluralityof spaced apart open through lumens/channels 312 can be coupled to thetrajectory frame 100. This guide 311 can be used to place/inserttherapeutic devices 1000 into the patient to the target site. Themulti-lumen guide 311 can have the same number of channels 312 as thefluid filled guide 211 and these channels 312 can be in the sameposition. As shown, there are seven channels 312.

The guide 311 can have an external alignment feature 313 that cooperateswith feature 139 in the platform 132 so that it the channels 311 havethe same orientation as the channels 211 f when attached to theplatform. The alignment feature 313 can have the same shape as that of213 of the guide 211 with the fluid filled lumen(s) 211 f. As shown, thealignment feature 313 is a projecting ledge while the mating feature 139(FIG. 11D) is an enlarged perimeter segment of the port 132. However,other affirmative alignment configurations may be used.

Still referring to FIGS.11A-11C, the device guide 311 can have aplurality of circumferentially spaced apart fixation members 319 thatreside on a top portion of the device guide and reside above theplatform 132, when in position (FIG. 11E). The fixation members 319 canlock against a therapeutic medical device 1000 to fix the device in alongitudinal position, i.e., so that the device 1000 cannot move up ordown (FIGS. 12A, 12B).

Referring to FIG. 11C, the device guide 311 with the open through lumens312 is shown adjacent the fluid filled lumen guide 211. As shown, thetop 311 t of the device guide 311 can have a planar surface and aperimeter region 320 that is free of any channels (unlike the alignmentchannels 211 i in the fluid-filled guide 211). That is, all channels 312can be open through channels and can have the same diameter.

FIG. 11D illustrates the multi-lumen guide 311 oriented to align withthe alignment feature 139. FIG. 11E illustrates the multi-lumen guide311 releasably coupled to the trajectory frame 100 with a lower portionthereof in the tubular support 204 and locked via fixation member 133.

FIG. 11F illustrates an example therapeutic device 1000 aligned with oneof the open channels 312 of the multi-lumen guide 311. The therapeuticdevice 1110 can have an adjustable depth stop member 1110. The insertiondepth calculated earlier can be marked on the device 1000, measuringfrom the distal end 1000 d. The depth stop 1110 can be attached so thata bottom of the depth stop is aligned with the depth mark 1100 m. Thedevice 1000 can then be inserted into the desired guide path of aselected open channel 312 until the depth stop bottoms out on top 311 tof the guide 311.

FIGS. 12A and 12B illustrate fixation members 319 that can be used tosecure the therapeutic device 1000 in place. A single therapeutic device1000 can be inserted through the multi-lumen guide 311 as shown in FIG.12A. Multiple therapeutic devices 1000 ₁, 1000 ₂, 1000 ₃ can be insertedthrough different channels 312 of the multi-lumen device 311 to beconcurrently in position as shown in FIG. 12B.

In some embodiments, the entire procedure can be carried out inside anMRI scanner room of an MRI suite and a different set of trajectoryalignment and selection tools can be used from that shown in FIGS.5A-5H.

Referring now to FIG. 13A, a fluid-filled grid 277 can be placed on asubject, i.e., on the head and/or skull S. An MRI scan can be performedencompassing the volume of the grid 277 and the intrabody target regionof interest. The surgeon can choose an entry point through the grid 277using automated or semi-automated trajectory selection/identificationnavigation systems. See, U.S. Pat. Nos. 8,195,272 and 8,315,689, thecontents of which are hereby incorporated by reference as if recited infull herein. As discussed above, a surgeon can elect Option 1 (twistpoint entry via a twist drill) or Option 2 (larger burr hole) optionsfor creating access for the surgical procedure. For the twist pointentry, the centering screw guide 10 (FIGS. 2D, 2E) that uses a bonescrew to directly anchor over the selected entry point can be used.

Referring to FIGS. 13A-13C, the fluid-filled top 277 t of the grid 277can be peeled off, leaving the base grid exposed 277 b. The centeringscrew guide 10 can be coupled to the skull using a screw driver 15,directly onto the selected entry point through the grid base 277 b.Referring to FIG. 13D, the primary body 10 b of the centering guide 10can be removed leaving the centering guide bone screw 10 s in placethrough the grid base 277 b. As shown in FIG. 13E, the grid 277 isremoved (peeled off the skull), leaving the centering screw 10 s inplace attached to the skull. The centering guide body 10 b can bereattached to the screw 10 s so that the centering tool 18 (FIG. 2D, 2E)can be inserted directly over it. As discussed above with respect toFIGS. 2D and 2E, the centering tool 18 (FIG. 2D) can be attached to thecentering screw guide (concentrically over and onto the guide 10).

If Option 2 is elected, the surgeon can make a divot on the patientskull through the selected entry point on the marking grid using amarking too. Then, the same protocol as discussed with respect to FIGS.2F and 2G can be used to create a relatively large burr hole in thepatient's skull.

As discussed above with respect to FIGS. 3A-3C, the base 110 of thetrajectory frame 100 can be centered over the centering tool 18 andcoupled to the patient's skull through the scalp. Once the scalp mountbase 110 is secured, the centering tool 18 and guide 10, if used, areremoved. As discussed above with respect to FIGS. 4A-4E, the upperportion 100 u of the trajectory frame 100 can be attached to the base110.

Referring now to FIGS. 14A-14D, a targeting cannula 111 can be coupledto the trajectory frame 100 using the fixation thrum screw 133. Thetargeting cannula 111 has a fluid filled lumen (fluid column) 111 f anda cap 111 c. The targeting cannula 111 has a tubular body that has theinner lumen with a closed bottom end and a larger diameter reservoir 111r above the fluid column 111 f. The bottom 111 b can extend out of thebottom of the tower or tubular member 204 when in position as shown inFIGS. 14C and 14D. An MRI scanner can scan the image volume with theintrabody target region of interest and the targeting cannula 111 and asurgical navigation system can electronically calculate positionaladjustments (i.e., knob rotations for pitch and roll adjustment) toalign the trajectory of the tubular member/tower 204 to the desiredtrajectory. FIGS. 14E and 14F illustrate example pitch adjustment usingpitch actuator 140 a. FIGS. 14G and 14H illustrate example rolladjustment using roll actuator 140 b.

FIGS. 14B and 14C illustrate that the pitch actuator 140 a′ can beparallel to the tubular member 204 and/or device guide 311 or fluidfilled guide 211 and can reside above the platform 132 on a corner ofthe platform 132 as shown. Thus, the roll and pitch actuators 140 b, 140a can be parallel to each other and extend in an upright direction.

After the trajectory adjustments to the tower 204 of the trajectoryframe 100, either via the navigation stylus 5 (FIG. 5C) discussed aboveor a targeting cannula 111, a multi-lumen fluid filled guide array 211can be used to determine a trajectory selection channel of a guide 311as discussed above (FIGS. 6A-6C, FIGS. 7A-7E and 8). Once the guidearray 211 is inserted, an MRI scan that encompasses the volume of thetrajectory frame 100 and the intrabody region of interest/target can beperformed and pitch and roll adjustments made. The navigation stylus 5can be used for the CT imaging modality while an MR visible targetingcannula 111 and/or fluid-filled array 211 can be used for an MRI onlyworkflow.

Thus, in some embodiments, after a trajectory is set, the targetingcannula 111 can be removed from the tower 204, and a fluid-filled guidearray 211 can used to pick a path to the target. There are a plurality(shown as seven) possible device paths included in the guide array 211,to give the surgeon multiple options for selecting the safest path toreach the desired target. Also, these additional paths act as a way tocounter-act any mounting errors that may have occurred.

The fluid filled guide channels 211 f (FIGS. 6D, 6E) of the guide array211 will be bright parallel lines on an MRI image obtained by an MRIscan or scans. The surgeon can select the lumen position in the arraythat most closely matches the desired insertion path/trajectory.

Alternatively, instead of (or even in combination with) the physicalguide array 211, a virtual a multi-lumen fluid filled guide array 1211(FIG. 15A) can be generated programmatically, and digitally overlaidonto an MRI image comprising the trajectory frame 100. Thus, the virtualarray 1211 can be used to select a corresponding lumen position in amulti-lumen guide 311 (FIGS. 8 and 11A-11C) as will be discussed below.

As shown in FIG. 15A, a surgical system 1400 can include an imageprocessing circuit 1600 in communication with the display 1610. Theimage processing circuit 1600 can generate an image 1500′ that aligns avirtual guide array 1211 and the axis of the tubular member 204 held bythe trajectory guide assembly 100.

Referring to FIGS. 15A and 15B, once a “final” or “set” trajectoryalignment has been made, a user interface can prompt a user to select adesired trajectory. The surgical navigation system 1400 can include adisplay 1610 in communication with a processor 1160 with a virtual arraymodule 1512 that can programmatically generate and automatically overlaya virtual guide array 1211 onto an image 1500′, centered axially(indicated by cross-hair center) on longitudinal axis 204A of the tower204. The system 1400 can be in communication with or at least partiallyonboard a medical imaging system 1515 such as an MRI imaging system(and/or optionally a CT imaging system). The processor 1600 and display1610 can be provided as components of a workstation 1514.

The system 1400 can automatically orient the virtual array 1211optionally based on orientation of circumferentially spaced apartfiducial markers 119 (FIGS. 3A, 7C) on the base 110 of the trajectoryframe 100. The virtual array 1211 matches the virtual channels 1211 cwith the physical channels of the multi-lumen guide 311 (FIGS. 8,11A-11C, 15B) and orientation indicia 132 i on platform 132 (FIGS. 7E,15B). The virtual array 1211 can include a plurality ofcircumferentially and radially spaced apart virtual channels 1211 c,shown as seven channels numbered as channels 1-7, with a center channel(channel 7) surrounded by a concentric set of six equallycircumferentially spaced apart channels (numbered as channels 1-6). Thevirtual array 1211 can also include virtual orientation indiciaincluding a virtual patient left directional indicator 1213 and avirtual directional patient right directional indicator 1214 (shown as apair of right side markings). The virtual patient left marking 1213 canbe aligned and provided to visually match or correspond to the patientleft marking 132 il (on the platform 132) and the virtual patient rightmarking 1214 can visually correspond to the patient right marking 132 ir(on the platform 132) with the virtual markings positioned aligned butradially spaced apart and closer to the tubular member 204 and/or centerof the platform 132 than the physical markings 132 i. The surgeon thenselects which path (virtual channel 1211 c) most closely matches thedesired trajectory.

If the user has opted to create a smaller entry hole with a twist pointdrill, then the protocol discussed above with respect to FIGS. 8, 9A-9C,10A-10H can be performed followed by the use of the multi-lumen guide311 discussed with respect to FIGS. 11A-11C. If a burr hole entry wasperformed, then the multi-lumen guide 311 can be attached to thetrajectory frame 100 without requiring the twist entry tools and steps.

FIG. 16 is a flow chart of example actions that can be used for surgicalnavigation for a therapeutic treatment according to embodiments of thepresent invention. A trajectory guide assembly can be affixed to asubject (block 1600). A cooperating device comprising either a targetingcannula with a single fluid filled lumen or a guide array with multiplefluid filled lumens can be inserted into a tubular member (tower) of thetrajectory guide assembly (block 1610). A desired trajectory can beidentified using the inserted device (block 1620). The device can bereplaced with a device guide having a plurality of open lumens (block1630).

The insertion can be carried out by inserting the targeting cannula(block 1612). The method can include generating an image with thetrajectory guide assembly and a virtual array of lumens corresponding tothe lumens of the device guide aligned to a longitudinally extendingaxis of the tubular member held by the trajectory guide assembly (block1614). There can be between 5-9 parallel and open through lumens in abody of the device guide that extends above and below the tubular member(block 1632). The tubular member can be held directly on a platform withorientation indicia and the virtual array can also include orientationindicia corresponding to that on the platform (block 1634).

The surgical navigation system 1500 (FIG. 15A) can take the form of anentirely software embodiment or an embodiment combining software andhardware aspects, all generally referred to herein as a “circuit” or“module”. Furthermore, the present invention may take the form of acomputer program product on a computer-usable storage medium havingcomputer-usable program code embodied in the medium. Any suitablecomputer readable medium may be utilized including hard disks, CD-ROMs,optical storage devices, a transmission media such as those supportingthe Internet or an intranet, or magnetic storage devices. Some circuits,modules or routines may be written in assembly language or evenmicro-code to enhance performance and/or memory usage. It will befurther appreciated that the functionality of any or all of the programmodules may also be implemented using discrete hardware components, oneor more application specific integrated circuits (ASICs), or aprogrammed digital signal processor or microcontroller. Embodiments ofthe present invention are not limited to a particular programminglanguage.

Computer program code for carrying out operations of data processingsystems, method steps or actions, modules or circuits (or portionsthereof) discussed herein may be written in a high-level programminglanguage, such as Python, Java, AJAX (Asynchronous JavaScript), C,and/or C++, for development convenience. In addition, computer programcode for carrying out operations of exemplary embodiments may also bewritten in other programming languages, such as, but not limited to,interpreted languages. Some modules or routines may be written inassembly language or even micro-code to enhance performance and/ormemory usage. However, embodiments are not limited to a particularprogramming language. As noted above, the functionality of any or all ofthe program modules may also be implemented using discrete hardwarecomponents, one or more application specific integrated circuits(ASICs), or a programmed digital signal processor or microcontroller.The program code may execute entirely on one (e.g., a workstationcomputer), partly on one computer, as a stand-alone software package,partly on the workstation's computer or Scanner's computer and partly onanother computer, local and/or remote or entirely on the other local orremote computer. In the latter scenario, the other local or remotecomputer may be connected to the user's computer through a local areanetwork (LAN) or a wide area network (WAN), or the connection may bemade to an external computer (for example, through the Internet using anInternet Service Provider).

The present invention is described in part with reference to flowchartillustrations and/or block diagrams of methods, apparatus (systems) andcomputer program products according to embodiments of the invention. Itwill be understood that each block of the flowchart illustrations and/orblock diagrams, and combinations of blocks in the flowchartillustrations and/or block diagrams, can be implemented by computerprogram instructions. These computer program instructions may beprovided to a processor of a general purpose computer, special purposecomputer, or other programmable data processing apparatus to produce amachine, such that the instructions, which execute via the processor ofthe computer or other programmable data processing apparatus, createmeans for implementing the functions/acts specified in the flowchartand/or block diagram block or blocks.

These computer program instructions may also be stored in acomputer-readable memory that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablememory produce an article of manufacture including instruction meanswhich implement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer orother programmable data processing apparatus to cause a series ofoperational steps to be performed on the computer or other programmableapparatus to produce a computer implemented process such that theinstructions which execute on the computer or other programmableapparatus provide steps for implementing some or all of thefunctions/acts specified in the flowchart and/or block diagram block orblocks.

The flowcharts and block diagrams of certain of the figures hereinillustrate exemplary architecture, functionality, and operation ofpossible implementations of embodiments of the present invention. Inthis regard, each block in the flow charts or block diagrams representsa module, segment, or portion of code, which comprises one or moreexecutable instructions for implementing the specified logicalfunction(s). It should also be noted that in some alternativeimplementations, the functions noted in the blocks may occur out of theorder noted in the figures. For example, two blocks shown in successionmay in fact be executed substantially concurrently or the blocks maysometimes be executed in the reverse order or two or more blocks may becombined, depending upon the functionality involved.

As illustrated in FIG. 17, embodiments of the invention may beconfigured as a data processing system 2000, which can be used to carryout or direct operations of the surgical navigation system 1400, and caninclude a processor 1600, a memory 2336 and input/output circuits 2346.The data processing system may be incorporated in, for example, one ormore of a personal computer, workstation 1514 (FIG. 15A), server(s) orthe like. The system 2000 can reside on one machine or be distributedover a plurality of machines and/or be a cloud based system. Theprocessor 1600 communicates with the memory 2336 via an address/data bus2348 and communicates with the input/output circuits 2346 via anaddress/data bus 2349. The input/output circuits 2346 can be used totransfer information between the memory (memory and/or storage media)2336 and another computer system or a network using, for example, anInternet protocol (IP) connection. These components may be conventionalcomponents such as those used in many conventional data processingsystems, which may be configured to operate as described herein.

In particular, the processor 1510 can be commercially available orcustom microprocessor, microcontroller, digital signal processor or thelike. The memory 2336 may include any memory devices and/or storagemedia containing the software and data used to implement thefunctionality circuits or modules used in accordance with embodiments ofthe present invention. The memory 2336 can include, but is not limitedto, the following types of devices: ROM, PROM, EPROM, EEPROM, flashmemory, SRAM, DRAM and magnetic disk. In some embodiments of the presentinvention, the memory 336 may be a content addressable memory (CAM).

As further illustrated in FIG. 17, the memory (and/or storage media)2336 may include several categories of software and data used in thedata processing system: an operating system 2352; application programs2354; input/output device drivers 2358; and data 2356. As will beappreciated by those of skill in the art, the operating system 2352 maybe any operating system suitable for use with a data processing system,such as IBM®, AIX® or zOS® operating systems or Microsoft® Windows2000or WindowsXP operating systems, Windows Visa, Windows7, Windows CE orother Windows versions from Microsoft Corporation, Redmond, Wash., PalmOS, Symbian OS, Cisco IOS, VxWorks, Unix or Linux™ Mac OS from AppleComputer, LabView, or proprietary operating systems. IBM, AIX and zOSare trademarks of International Business Machines Corporation in theUnited States, other countries, or both while Linux is a trademark ofLinus Torvalds in the United States, other countries, or both. Microsoftand Windows are trademarks of Microsoft Corporation in the UnitedStates, other countries, or both. The input/output device drivers 2358typically include software routines accessed through the operatingsystem 2352 by the application programs 2354 to communicate with devicessuch as the input/output circuits 2346 and certain memory 2336components. The application programs 2354 are illustrative of theprograms that implement the various features of the circuits and modulesaccording to some embodiments of the present invention. Finally, thedata 2356 represents the static and dynamic data used by the applicationprograms 2354 the operating system 2352 the input/output device drivers2358 and other software programs that may reside in the memory 2336.

The data 2356 may include (near real time or archived or stored) digitalimage data sets 2326 that provide image data including image volumesencompassing the trajectory frame and intrabody target (typically alsocomprising DICOM data to correlate the image data to respectivepatients). The data 2356 may include defined trajectory frameorientation features such as fiducial features and positions fordefining an orientation of the trajectory frame 100 in image spaceand/or to patient right, patient front and patient left.

As further illustrated in FIG. 17, according to some embodiments of thepresent invention application programs 2354 include a Device GuideModule for a device guide with a plurality of parallel open lumens 2324and an optional Virtual Array Module 1512. The application program 2354may be located in a local server (or processor) and/or database or aremote server (or processor) and/or database, or combinations of localand remote databases and/or servers.

While the present invention is illustrated with reference to theapplication programs 2354, and Modules 2324, 1512 in FIG. 17, as will beappreciated by those of skill in the art, other configurations fallwithin the scope of the present invention. For example, rather thanbeing application programs 2354 these circuits and modules may also beincorporated into the operating system 2352 or other such logicaldivision of the data processing system. Furthermore, while theapplication programs 2354 are illustrated in a single data processingsystem, as will be appreciated by those of skill in the art, suchfunctionality may be distributed across one or more data processingsystems in, for example, the type of client/server arrangement describedabove. Thus, the present invention should not be construed as limited tothe configurations illustrated in FIG. 17 but may be provided by otherarrangements and/or divisions of functions between data processingsystems. For example, although FIG. 17 is illustrated as having variouscircuits and modules, one or more of these circuits or modules may becombined or separated without departing from the scope of the presentinvention.

In particular embodiments, the system 1400 can include or be incommunication with a PACS (picture archiving and communication) system.The system 1500 can include, for example, at least one server and/or atleast one (clinical) client (e.g., workstation).

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. The invention is defined by the following claims, withequivalents of the claims to be included therein.

That which is claimed is:
 1. A method of introducing a device into asubject, comprising: placing a trajectory frame over or on a subject,the trajectory frame comprising a base and a platform residing above thebase, the platform comprising an open port; inserting a trajectoryselection guide through the port and securing the trajectory selectionguide to the platform, wherein the trajectory selection guide has asingle longitudinally extending fluid-filled lumen or is provided as amulti-lumen guide array with a plurality of longitudinally extendingfluid filled channels; identifying a desired intrabody trajectory;removing the trajectory selection guide from the platform; inserting adevice guide into the port and securing the device guide to theplatform, wherein the device guide comprises at least one open throughchannel that extends in a longitudinal direction; and introducing adevice into a respective channel of the at least one open channel of thedevice guide and into the subject.
 2. The method of claim 1, wherein thetrajectory selection guide is provided as the multi-lumen guide array,the method further comprising: electronically generating a virtualmulti-lumen guide array with a plurality of longitudinally extendingparallel virtual channels; electronically aligning the generated virtualmulti-lumen guide array with an image of the trajectory frame and/ortrajectory selection guide, wherein the virtual multi-lumen guide arraycomprises a plurality of radially and/or circumferentially spaced apartvirtual channels spaced apart about a virtual center channel in apattern corresponding to positions of the fluid filled channels of themulti-lumen guide array; and displaying an image with the virtualmulti-lumen guide array overlaid on the trajectory frame and/ortrajectory selection guide.
 3. The method of claim 2, wherein theelectronically aligning is carried out by identifying orientationfeatures of the trajectory selection guide in MRI image data andaligning the virtual center channel with a center of the open port ofthe platform.
 4. The method of claim 1, wherein the at least one openthrough channel of the device guide is a single open through channel,wherein the single open through channel is a longitudinally extendingopen channel that is radially offset from a longitudinally extendingcenterline of the device guide, and wherein the method further comprisesrotating the device guide to a desired position before or during theintroduction of the device into the single open through channel of thedevice guide.
 5. The method of claim 4, wherein the trajectory selectionguide comprises the multi-lumen guide array, and wherein the rotating iscarried out to align the single open through channel of the device guidewith a selected one lumen of the lumens of the multi-lumen guide array.6. The method of claim 1, wherein the trajectory selection guide and thedevice guide each serially extend through the port of the platform witha respective bottom portion thereof a distance below the platform. 7.The method of claim 1, wherein the platform comprises visual orientationindicia on an upper surface thereof that includes a patient rightdirectional indicator, a patient left directional indicator and aforward directional indicator, wherein the patient right directionalindicator, the patient left directional indicator and the forwarddirectional indicator are provided as respective markings that arespaced apart on the upper surface, wherein the trajectory selectionguide member is the multi-lumen guide array, wherein the plurality oflongitudinally extending fluid filled channels comprise a center channelwith adjacent channels residing spaced apart about the center channel,wherein the multi-lumen guide array comprises orientation indiciacorresponding to patient directions of right, left and forward, andwherein the method further comprises aligning the visual orientationindicia of the platform with the orientation indicia of the multi-lumenguide array before or during identifying the desired trajectory.
 8. Themethod of claim 1, wherein the trajectory selection guide comprises acap sealably attached to and enclosing a primary body, wherein the capresides above a liquid reservoir, and wherein the liquid reservoir has awidth that is larger than a width of the at least one longitudinallyextending fluid filled lumen and merges into the at least onelongitudinally extending fluid filled channel.
 9. The method of claim 1,wherein the platform is rectangular and comprises a tubular supportmember which extends above and below the open port, wherein the openport of the platform comprises a perimeter with an alignment featurethat circumferentially extends about a sub-set of the perimeter, themethod further comprising mating an alignment feature on the deviceguide with the alignment feature of the platform.
 10. The method ofclaim 1, wherein the device guide is a first device guide, the methodfurther comprising releasably and interchangeably inserting a seconddevice guide into the port and securing the second device guide to theplatform in place of the first device guide, wherein the second deviceguide comprises a longitudinally extending open channel that is centeredwith an axially extending centerline of the second device guide.
 11. Themethod of claim 1, wherein the trajectory frame comprises a pair ofarcuate laterally spaced apart arms that hold the platform therebetweenand above the base and has only two actuators for pitch and roll, andwherein the trajectory guide assembly is devoid of x-y directionactuators.
 12. The method of claim 1, wherein the trajectory selectionguide is provided as the multi-lumen guide array with a plurality ofradially and/or circumferentially spaced apart fluid filled lumensspaced apart about a center fluid filled lumen, and wherein theplurality of fluid filled channels of the multi-lumen guide array isseven.
 13. The method of claim 1, wherein the identifying the desiredtrajectory comprises generating and displaying a virtual multi-lumenguide array that is aligned with an image of the trajectory frame and/ortrajectory selection guide, wherein the virtual multi-lumen guide arraycomprises a plurality of radially and/or circumferentially spaced apartvirtual channels spaced apart about a virtual center channel, andwherein the virtual center channel is aligned with a center of the openport of the platform.
 14. The method of claim 13, further comprising:generating the plurality of radially and/or circumferentially spacedapart virtual channels in a lateral section view; and displaying aplurality of virtual directional indicia features adjacent the virtualchannels.
 15. The method of claim 13, wherein the displaying the virtualmulti-lumen guide array is carried out by displaying the virtualmulti-lumen guide array with a plurality of circular virtual channels asthe plurality of radially and/or circumferentially spaced apart virtualchannels spaced apart about the virtual center channel.